
Amy Minshall, ABOC
Optician

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About me
Clinical Trial Manager | ABO Certified Optician
Education

California State University, Fullerton
2005 - 2008Bachelor's Biology with a concentration in cell and devlopmental biology
Experience

Marshall Field's Optical, a US Vision Company
Oct 2000 - Jun 2002Optician· Answered phones and booked appointments· Aided patients with frame selection and dispensed glasses· Taught patients how to insert, remove, and maintain contact lenses· Verified prescriptions of incoming lab orders before dispensing

RXOptical
Jun 2002 - Aug 2003Certified Optician· Answered phones and booked appointments· Aided patients with frame selection and dispensed glasses· Taught patients how to insert, remove, and maintain contact lenses

Richard Sarlitt, OD AOC
Aug 2003 - Sept 2008Certified Optician· Answered phones, booking appointments, and ordering contact lenses and eyeglass frames· Aided patients with frame selection and dispensing glasses· Taught patients how to insert, remove, and maintain contact lenses· Performed Humphrey visual fields, NCT, digital fundus photos, and auto-refraction

Pacira Pharmaceuticals, Inc.
Sept 2008 - Dec 2008Research Associate I, Microbiology-Aseptic Class 100,000 gowning and environmental monitoring-Operated Met One particle counter, RCS air sampler, and slit to agar-Sampled water, nitrogen, clean steam, and clean compressed air (CCA) -Manufactured media (TSA, TSB, SAB broth, SAB agar, Fluid D, SDS, glycerin)

EBioscience
Jan 2009 - Jul 2011Research Associate II, R&D-Chemical modification/activation of fluorescent molecules, antibodies, recombinant proteins, bioconjugation, and purification-Product stability and formulation-Transfer of process specifications and protocols to manufacturing

Family Vision Care
Jul 2011 - Oct 2013Lab Manager-Performed pre-testing for patients including auto-refraction, non-contact tonometry, Optos retinal imaging, topography, OCT and FDT.-Frame style using lifestyle dispensing-Contact lens trainings-Edged SV, FT, TF, and PAL lenses on Santinelli Lex 1000 with ICE Mini+ CAD blocker-Verified prescriptions received from outside labs-Monitored accuracy and timely delivery of jobs returning from outside labs-Maintained stock of lens blanks-Acted as patient care coordinator for Lasik patients at Gordon Weiss Schanzlin Vision Institute Show less

Sports Fan News
Jan 2013 - Aug 2014Writer• Created content for the Sports Fan News blog, focusing on the Oakland Raiders from a passionate fan's perspective.• Increased blog traffic through engaging articles and active social media promotion.• Worked closely with a content editor and managing editor to produce one article per week.

Global Laser Vision
Oct 2013 - Apr 2015Optical Manager-Maintaining frame inventory-Fitting patients according to lifestyle dispensing-Contact lens trainings-Verifying accuracy of prescriptions created at outside labs

Cover32
Aug 2014 - Feb 2017Writer• As one of the two primary writers covering the Oakland Raiders for Cover32, I delivered in-depth analysis, breaking news updates, and game recaps.• Regularly conducted radio, vlog, and podcast interviews to discuss the Raiders and promote Cover32's coverage.• Provided real-time in-depth coverage on the Raiders' draft picks to provide readers with the rookies’ backgrounds.• Worked closely with the managing editor to produce two articles per week or more dependent upon time of year.• Some of my Cover32 articles are still featured on Yahoo Sports. Show less

Gordon Schanzlin New Vision Institute
May 2015 - Jun 2017Lead Optician• VSP, MES, and EyeMed billing as well as obtaining VSP, MES, and EyeMed authorizations• Frame selection with patients based on lifestyle dispensing and patient education• Teaching patients how to insert, remove, and maintain contact lenses (soft, hard, scleral, and SynergEyes)• Verifying prescriptions received from outsourced labs and handling returns of lab remakes• Monitoring jobs in process at the lab to ensure accurate and timely delivery• Pre-testing patients using OCT iWellness and anterior seg, FDT, Optos, Annidis, and topography and Pentacam when necessary Show less

Scripps Poway Eyecare
Jun 2017 - Aug 2023Clinical Research Coordinator• Managed subject recruitment, conducted informed consent, and conducted study procedures.• Maintained all logs (enrollment, informed consent, ICF version, device accountability, IP accountability, AE, calibration, training, DOA, and PD) to ensure completeness and accuracy.• Completed source documents according to GDP and ensured data entry into EDC was completed in a timely manner.• Responded to queries in EDC.• Acted as liaison between site, sponsor, and CRO and was present for all IMVs with CRAs to provide clarification and any corrections needed.• Maintained inventory of investigational products and investigational devices.• Ensured Regulatory Binder was up to date with all current credentials and training along with all correspondence between site and CRO, sponsor, and/or IRB.• Trained other study coordinators.• Created source documents and SOPs for site implementation. Show less

Various
Apr 2019 - May 2024Clinical Research ExperienceTherapeutic Areas: Ophthalmology• Pivotal device study. 2024, Clinical Trials Manager and Clinical Research Coordinator.• Pivotal device study. 2024, Clinical Trials Manager.• Data collection study. 2024, Clinical Research Associate.• Device Feasibility Studies. 2023-2024, Various Roles.o Device and Toric Lens Sub-Study. 2024, Clinical Research Associate.o Device and Sodium Fluorescein Sub-Study. 2024, Clinical Research Coordinator.o Device and Anterior Segment Abnormalities Sub-Study. 2024, Clinical Research Coordinator.o Device Capability Validation Sub-Study. 2024, Clinical Research Associate.o Device and varied lighting settings sub-study. 2023, Clinical Research Associate.o Water – IOP Sub-Study. 2023, Clinical Research Associate.o Device Angles and Agreement Sub-Study. 2023, Clinical Research Associate.o Device Repeatability Sub-Study. 2023, Clinical Research Associate.• Investigator Initiated Trial. After market contact lens study. 2023, Clinical Research Coordinator.• Contact Lens Study for Myopia Control in a Pediatric Population. 2023, Clinical Research Coordinator. • Comparative Contact lens study. 2022, Clinical Research Coordinator.• Myopia control lens study in Pediatric population. 2021, Clinical Research Coordinator.• Phase III: Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults. 2021, Clinical Research Coordinator.• Comparing the Performance of 1 Day Multifocal Contact Lenses. 2020, Clinical Research Coordinator.• Phase III: A Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy of Ophthalmic Solution for the Treatment of Myopia in Children. 2019, Clinical Research Coordinator. Show less

Topcon Healthcare
Aug 2023 - May 2024Clinical Trial Manager• Developed device training documents based off device user manual, protocol, and hands-on training from engineers.• Used completed training documents to conduct staff training sessions at SIVs after installing the investigational device on-site.• Facilitated shipping/receiving and importing/exporting of investigational devices to/from sites and headquarters.• Contributed to drafting CRFs, revised (CRF completion, GCP, and GDP) training decks, and SOPs and also created supplemental form templates for SOPs.• Prepared regulatory binders for sites by collecting current credentials from all site staff and provided protocol specific documents (including copies of user manuals for investigational and comparator devices, training documents, training decks used at SIV for training sessions, blank CRFs, logs, etc.)• Created and maintained eTMF for all studies.• Conducted routine monitoring and audits for in-house feasibility studies to ensure adherence to GCP and ICH guidelines, protocol, and GDP.• Identified potential study sites for future projects and contributed to proofreading Clinical Study Reports.• Maintained inventory of gift cards for subject compensation. Show less

Centennial Family Eyecare
Nov 2024 - Feb 2025Assistant Manager, Clinical Research Coordinator• Responsible for bringing studies into the site• Contributed to all phases of primary care for patients including, but not limited to, billing (VSP, MES, EyeMed), frame selection according to lifestyle dispensing, contact lens (SCL, RGP, scleral, SynergEyes) trainings, and pre-testing.• Responsible for ordering jobs for all locations and following up on claims with the billing department• Managed a staff of eight

Thermo Fisher Scientific
Feb 2025 - nowClinical Research Manager
Licenses & Certifications

ICH Good Clinical Practice & FDA Guidance
ICHJan 2019
OHRP Human Subject Assurance
OHRPJan 2019
ABO
American Board of OpticianryMay 2003
OpenClinica Super User Training
OpenClinicaJan 2023
GCP for Clinical Trials Involving Investigational Medical Devices (international focus)
CITI ProgramJan 2022
GCP for Human Subjects Research, Biomedical
CITI ProgramJan 2022
Human Subject Protection
AdvarraJan 2023
Introduction to Clinical Research for sites
PPDJan 2020.webp)
NIDA CTN Good Clinical Practices
The National Institute on Drug Abuse (NIDA)Jan 2020
Medidata Rave Certified Clinical Research Coordinator
Medidata SolutionsJan 2020
Languages
- viVietnamese
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